CanadaBuys #25-58308

NRC Seeks Three Quality Control Consultants for Clinical Trial Material Facility in Montréal

The National Research Council Canada (NRC) is seeking professional Quality Control (QC) consulting services for its Clinical Trial Material Facility (CTMF) in Montréal, Quebec. - Government Buyer: - National Research Council Canada (NRC), HHT Branch, Clinical Trial Material Facility (CTMF) - Services Requested: - Three distinct QC consulting roles: - Senior QC Consultant: Establish QC processes for Phase 1 and 2 manufacturing, oversee environmental monitoring, documentation review, risk assessments, and validation protocols - Junior QC Consultant: Manage documentation review, data entry, incoming material management, raw material sampling, environmental monitoring, and analytical method transfer - QC Analyst-Sampler: Conduct environmental and water sampling in clean rooms (grade C and D), data entry for environmental monitoring, and support related QC tasks - Quantities: - 1 Senior QC Consultant (up to 1500 hours/year) - 1 Junior QC Consultant (up to 1620 hours/year) - 1 QC Analyst-Sampler (up to 1620 hours/year) - Unique/Notable Requirements: - Consultants must support compliance with Health Canada, US FDA, and European EMA regulations - Facility is GMP-compliant and focused on manufacturing vaccines and biologics for clinical trials - Bilingual proficiency in English and French is required - No products or equipment are being procured—only specialized consulting services - Workload estimates and vacation/holiday allowances are specified for each role - Open to international trade agreements and subject to NRC's Integrity Regime

Description

The National Research Council Canada (NRC) is seeking qualified consultants to provide Quality Control (QC) support for the operationalization of the Clinical Trial Material Facility (CTMF) in Montreal. The work must comply with Health Canada, FDA, and EMA regulations. The contract includes three lots: Senior QC to establish QC processes for Phase 1 and 2 manufacturing, Junior QC for documentation review and analytical method transfer, and QC Sampler for environmental monitoring sampling in clean rooms. The contract duration is 12 months with an anticipated start in mid-September 2026.

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